Liver shiver: Drug study's side effects scary

One of the lesser-known benefits of living near the UVA medical center is the chance to enroll in research studies: If you're willing to take some risks, you may get access to a new and more effective drug, medical device, or surgical technique before it's available to the general public.

That was Linda Borgo's understanding when she enrolled in a study of a new drug called duloxetine in May 2002.

Borgo signed a consent form that, over the course of 11 single-spaced pages, detailed all aspects of the study, including potential risks and the fact that it was a "double-blind" study. That means that neither Borgo nor the research team (UVA physician William Steers and the study coordinator, Gloria Carter) knew which subjects would get duloxetine and which a placebo. Only the drug's manufacturer, Eli Lilly & Company, would have access to that information.

The only side effect Borgo experienced during the first seven months was loss of appetite, which the consent form described as "very common." While this was worrisome, it wasn't dire. Right before Christmas, however, Borgo says things took a more serious turn.

A day or two before leaving for Florida, where she planned to spend the holiday with her children, Borgo had blood drawn as part of a scheduled study appointment. By Christmas Day, she claims, she was "sleeping 20 minutes of every hour." She returned to Charlottesville on December 26. "Luckily," she says, her children were driving– "because by that time I could barely stay awake."

When she got home, she found a voice-mail message from Carter. Both sides agree that Carter stated that Borgo's liver was not functioning, and that she was to stop taking the study pills immediately. She had also been withdrawn from the study.

This is where accounts diverge. Carter claims her message only instructed Borgo to stop taking the pills and notify her own doctor, as that person was prescribing another drug for Borgo and needed to be apprised of the situation. Borgo insists that because the study office was closed for the holidays, she was told not only to notifyher doctor, but to ask the doctor to perform a specific test as well

Possible liver damage is listed as a risk on the consent form, with the statement that the damage had usually been reversed "after patients stopped taking duloxetine," and "no permanent liver injury has been seen."

My communications with Carter were conducted through Peter Jump, director of public relations for the UVA Health System, which made it hard to determine what really happened. In any case, Borgo saw her own doctor exclusively from then on, and her liver function eventually returned to normal.

Although Carter claims she tried repeatedly to get Borgo to return for evaluation, Borgo denies this and says she would have preferred to be treated at UVA, but assumed– perhaps, she now concedes, wrongly– that she was being told to pursue the situation only with her own doctor.

When she was confident that everything was back to normal, Borgo sent copies of bills for her out-of-pocket expenses, which totaled $132.51, to Carter for reimbursement. To her surprise, Carter stated that she would not be reimbursed– although neither side can say what reason was given.

Here's the good news: UVA has now decided to reimburse Borgo. And I've discovered something in the consent form that might have saved her a lot of frustration: "If you have any questions regarding research participants' rights, please contact Dr. David A. Peura."

Peura is director of the Human Investigation Committee, which oversees all research on humans in the health system, and the consent form provides two phone numbers for him. Consent forms may be wordy, but they're definitely worth perusing.

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